Sleep in addiction care

Sleep in substance use disordered patients in addiction care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59953554

Enrollment

Registered

2008-08-19

Start date

2008-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia in patients with substance use disorder Mental and Behavioural Disorders Nonorganic sleep disorders

Interventions

The study is a randomised controlled trial in a cohort of patients referred to addiction care (2 addiction clinics). The duration of the study for the participating patients is 15 weeks, plus a follow

see primary and secondary outcome measures) and start standard treatment for their sleep problems. During the 4th week in treatment (T1), those who still continue with the treatment will be asked to u

http://www.ncbi.nlm.nih.gov/pubmed/10616231). The control group receives standard care (and no sleep training). This means a daily programme of cognitive therapy, group meetings, creative therapy, m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, age limit: 65 2. Patients who are admitted for at least 5 weeks to an addiction clinic 3. Those who are "clean" i.e. addicted patients that do not use drugs/alcohol anymore 4. Score of 5 or higher in the Pittsburgh Sleep Quality Index (PSQI)

Exclusion criteria

Exclusion criteria: 1. Patients with sleep problems other than problems of initiating or maintaining sleep 2. Diagnosis of severe depression, attention deficit hyperactivity disorder (ADHD) 3. Patients who have a primary benzodiazepine addiction

Design outcomes

Primary

Measure	Time frame
1. Subjective sleep efficiency as measured by a sleep log. The sleep log will be recorded by the participants during the 6-week treatment period. The sleep log has several outcome measures: time in bed (TIB), total sleep time (TST), sleep onset latency (SOL), sleep efficiency (SE), wake after sleep onset (WASO) and number of awakenings (AWAK). 2. Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) at timepoints T0, T1, T2, T3 and T4 Timepoints: T0 = Day of clinical intake T1 = 4th week of treatment T2 = 6th week of treatment, before randomisation T3 = At the end of sleep training T4 = 2 months after the sleep training	—

Measure

Time frame

1. Subjective sleep efficiency as measured by a sleep log. The sleep log will be recorded by the participants during the 6-week treatment period. The sleep log has several outcome measures: time in bed (TIB), total sleep time (TST), sleep onset latency (SOL), sleep efficiency (SE), wake after sleep onset (WASO) and number of awakenings (AWAK). 2. Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) at timepoints T0, T1, T2, T3 and T4 Timepoints: T0 = Day of clinical intake T1 = 4th week of treatment T2 = 6th week of treatment, before randomisation T3 = At the end of sleep training T4 = 2 months after the sleep training

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Secondary

Measure	Time frame
Vigilance during the day as measured by the Sustained Attention to Response Task (SART) at T1, T2, T3 and T4. SART will be carried out once a week during the period between T2 and T3. Tertiary outcome measures: 1. Severity of dependency on drugs/ alcohol measured by the Composite International Diagnostic Interview - Substance Abuse Module (CIDI-SAM) at T0 and T4 2. Addiction measured using the addiction scales of the Addiction Severity Index (ASI) at T0 and T4 3. Presence of any psychiatric disorder assessed by the Mini International Neuropsychiatric Interview (MINI) 4. Presence of sleep disorders assessed by the SLEEP-50 at T0, T1, T2, T3 and T4 5. Symptom assessment by the Symptom Check List (SCL-90) at T0, T1, T2, T3 and T4 6. Quality of life assessed by the EQ-5D at T0, T1, T2, T3 and T4 7. Actigraphy at T1, T2, T3 and T4. The actigraph registers movements of the right arm in right handed subjects for 48 hours or more. 8. Go/No-Go response-inhibition task (T1) Timepoints: T0 = Day of clinical intake T1 = 4th week of treatment T2 = 6th week of treatment, before randomisation T3 = At the end of sleep training T4 = 2 months after the sleep training	—

Measure

Time frame

Vigilance during the day as measured by the Sustained Attention to Response Task (SART) at T1, T2, T3 and T4. SART will be carried out once a week during the period between T2 and T3. Tertiary outcome measures: 1. Severity of dependency on drugs/ alcohol measured by the Composite International Diagnostic Interview - Substance Abuse Module (CIDI-SAM) at T0 and T4 2. Addiction measured using the addiction scales of the Addiction Severity Index (ASI) at T0 and T4 3. Presence of any psychiatric disorder assessed by the Mini International Neuropsychiatric Interview (MINI) 4. Presence of sleep disorders assessed by the SLEEP-50 at T0, T1, T2, T3 and T4 5. Symptom assessment by the Symptom Check List (SCL-90) at T0, T1, T2, T3 and T4 6. Quality of life assessed by the EQ-5D at T0, T1, T2, T3 and T4 7. Actigraphy at T1, T2, T3 and T4. The actigraph registers movements of the right arm in right handed subjects for 48 hours or more. 8. Go/No-Go response-inhibition task (T1) Timepoints: T0 = Day of clinical intake T1 = 4th week of treatment T2 = 6th week of treatment, before randomisation T3 = At the end of sleep training T4 = 2 months after the sleep training

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026